Childhood Acute Lymphoblastic Leukaemia: The Effect of Follow-Up Programs for Detection of Relapse. A Nordic Population-Based Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 277
- 试验地点
- 5
- 主要终点
- Detection mode
研究概览
简要总结
Over the past decades, advances in treatment have led to an increasing number of children who survive cancer, resulting in a growing population of childhood cancer survivors. After end of cancer treatment on common protocols survivors are enrolled in non-harmonized follow-up programs with frequent visits and blood samples. However, the evidence for the value of these follow-up programs with respect to the effect on detecting relapse and the effects on overall survival is scarce.
The aim of the study is to give a comprehensive description of the detection mode of relapsed acute lymphoblastic leukaemia (ALL), including symptoms and blood test results. Further, we aim to evaluate if the mode of detection affects survival.
详细描述
Investigators have identified a cohort of children with B-precursor ALL and T-ALL enrolled in the Nordic Society of Paediatric Haematology and Oncology (NOPHO) ALL-92, ALL-2000 and ALL-2008 trials and experienced a relapse or an SMN as the first event after cessation of maintenance therapy (368 patients). From medical charts and blood test results it will be decided whether the relapse/SMN was diagnosed at a routine visit (including routine blood tests) or if the relapse was diagnosed because of symptoms at a non-scheduled visit or blood test.
As the NOPHO database probably is one of the most complete databases globally, it is an advantage to perform this study as a NOPHO study.
Results of this population based relapse study will provide an evidence-based background for planning optimal and relevant follow-up programs for children after therapy of ALL treated according to contemporary Nordic ALL protocols.
The study is important and relevant in the light of today's high ALL cure rates and a need for optimal follow-up programs after cessation of ALL treatment and possible prediction of relapse.
The timing of the project is an increased focus on the clinical relevance of routine clinical follow-up of patients treated for cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with pre-B or T-cell ALL in the Nordic countries (Denmark, Sweden, Norway, Finland or Iceland)
- •included in the NOPHO ALL-92, ALL-2000 or ALL-2008 trials
- •treated in a Paediatric Department
- •developing a relapse/SMN after cessation of maintenance therapy before 31st of December 2016
排除标准
- •hematopoietic stem cell transplantation in first complete remission
结局指标
主要结局
Detection mode
时间窗: Investigators will review medical charts up to three months before the diagnosis of a relapse. Relapses will be categorized to be diagnosed by either a routine visit or an extra scheduled visit.
The proportion of relapses diagnosed at a routine visit vs. relapses diagnosed at an extra scheduled visit.
次要结局
- Survival(Time-to-Event measures (up to 23 years from date of relapse until censoring))